Tirofiban Impurity A, also designated debutylpiperidine tirofiban, is a process-related structural variant of the GP IIb/IIIa antagonist tirofiban, associated with N-dealkylation of the piperidine side chain during synthesis or storage. This nonclassical impurity, CAS 149490-60-8, has molecular formula C13H19NO5S and molecular weight 301.36 g/mol. Its polarity and low-level occurrence typically necessitate LC-MS/MS or high-resolution LC-MS for characterization, with orthogonal confirmation by HPLC and NMR. From a regulatory perspective, it is evaluated as a specified impurity, with attention to impurity qualification and ICH M7 principles where applicable.
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